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NCT05224817 Clinical Trial

NECROtizing Soft Tissue Infections and Their Scoring System

Necrosis Clinical Trial

Official title:
Prospective, Multicenter Derivation and Validation of a NECROtizing Soft Tissue Infections (NECROSIS) Score

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05224817
Other study ID # 056.GME.2019.D
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date January 30, 2023

Study information
Verified date February 2022
Source Methodist Health System
Contact Crystee Cooper, DHEd
Phone 214-947-1280
Email ClinicalResearch@mhd.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Primary Objective: The primary objective of this study is to develop and validate a clinical risk index score for identifying NSTIs in emergency general surgery patients being evaluated for a severe skin and soft tissue infection. Secondary Objectives: To describe the contemporary microbiology of NSTIs and explore the effects on outcomes and to identify predictors of amputation and mortality.

Description:

This study is designed as a multicenter, prospective, observational study. There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center. We plan to complete the data collection and analysis by 12/30/2021.

Recruitment information / eligibility
Status Recruiting
Enrollment 1010
Est. completion date January 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - All adult patients (age =18 years old and =89 years old) with suspected or confirmed NSTI Exclusion Criteria: - Age <18 years old and age > 89 years - Pregnancy - Prisoners - Below ankle diabetic foot infections complicated by peripheral vascular disease - Burn wounds

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Necrotizing soft tissue infections (NSTIs)
There will be no direct interaction with subjects and involves no interventions; study is conducted completely via review of electronic health records. Our site will only collect data from the Methodist Dallas Medical Center.

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the presence of necrosis presence of necrosis-"dishwater" fluid or deliquescent tissues up to 30 days
Primary Change in the presence of necrosis thrombosed vessels or absence of bleeding up to 30 days
Primary mortality length of time in hospital 30-90 days
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